Pancreatic Cancer
Conditions
Brief summary
This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the corkscrew technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). It is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.
Interventions
PROCEDUREEUS-FNA with Corkscrew technique
DEVICEExpect 19 G Flex needle
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-Fine Needle Aspiration (FNTA)
Exclusion criteria
* Uncorrectable coagulopathy (INR \> 1.5) * Uncorrectable thrombocytopenia (platelet \< 50,000) * Uncooperative patients * Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures) * Refusal to consent form * Prior negative FNTA * In situ metallic biliary stents * Predominantly cystic lesions * Inaccessible lesions to EUS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield of the FNA Using Corkscrew Technique | 30 days | Diagnostic yield was defined as the proportion of masses in which the amount of FNA-obtained cellular material was enough for the histopathologist to make the pathological diagnosis. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled between 7/18/14 and 2/18/15 in an academic tertiary center
Pre-assignment details
A total of 4 participants were enrolled. However, 3 participants were excluded before being assigned to the study arm because the performing endoscopist didn't find it possible to do the procedure due to the unfavorable size of the mass or technical difficulty.
Participants by arm
| Arm | Count |
|---|---|
| Pancreatic Mass Patients with pancreatic mass presenting for EUS-FNA
EUS-FNA with Corkscrew technique
Expect 19 G Flex needle | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Pancreatic Mass |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 80 years |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Participants With Adverse Events as a Measure of Safety
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pancreatic Mass | Number of Participants With Adverse Events as a Measure of Safety | 0 participants |
Secondary
Diagnostic Yield of the FNA Using Corkscrew Technique
Diagnostic yield was defined as the proportion of masses in which the amount of FNA-obtained cellular material was enough for the histopathologist to make the pathological diagnosis.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pancreatic Mass | Diagnostic Yield of the FNA Using Corkscrew Technique | 0 percentage of masses |